Kornimate/medical-research-clean huggingface dataset:
thera-band® hep for lbp secondary prevention

Conditions: Low Back Pain

Summary: the purpose of this study is to determine the effectiveness of a thera-band based home exercise program (hep) on lbp and disability 4 weeks post treatment discharge.

the effectiveness of interventions for the treatment of acute and chronic lbp has been extensively studied, but study of the strategies for preventing the progression of acute lbp episodes into chronic back pain is still lacking. therefore, determining the most effective secondary prevention strategy for the prevention of recurrences of lbp is essential for the reduction of long term disability. the purpose of this study is to determine the effectiveness of a thera-band based home exercise program (hep) on lbp and disability 4 weeks post treatment discharge. a convenience sample of 22 new patients, 18-65 years of age, with current, chronic lbp will be recruited for this study at the discharge visit from care. exclusionary criteria will include, current pregnancy and the presence of any red flags such as tumor or cancer, vertebral fracture, or infection. upon agreeing to the study, patients will sign an informed consent, complete a demographics questionnaire, and complete specific outcome measure assessments. the outcome measures will include numeric pain rating scale (nprs) and oswestry disability index (odi). additionally, subjects will be asked to complete a secondary prevention program questionnaire. following the initial paperwork, all patients will be provided with a thera-band® loop and band and handout describing the hep to be performed 3 times a week for 4 weeks. at the conclusion of 4 weeks, a follow-up phone call or email, based on patient preference, will be conducted. the follow-up will include pain, disability, compliance, satisfaction of program of the home program.

Eligibility criteria:
inclusion criteria: * current, chronic low back pain * discharging from care exclusion criteria: * current pregnancy * presence of any red flags such as tumor or cancer, vertebral fracture, or infection

Keywords: home exercise resistance exercise
music listening for cardiorespiratory exercise in inpatient stroke rehabilitation

Conditions: Stroke

Summary: stroke survivors struggle to meet clinical recommendations for physical exercise duration and intensity. during the past two decades, music interventions have increasingly shown effectiveness in several motor tasks in stroke rehabilitation. additionally, music has been found effective in increasing exercise performance in athletes and other clinical populations. based on a meta-theoretical review paper by clark, baker \& taylor (2016), it was hypothesized that the therapeutic effects of music in physical exercise is modulated by the preference and task-specificity of the music. we will test this hypothesis using a three-armed randomized cross-over design comprised of the following auditory conditions: 1) a group-tailored playlist 2) radio as active control and 3) a non-music control condition during cycle ergometry cardiorespiratory exercise sessions. participants are inpatient stroke survivors undergoing rehabilitation between 2-12 weeks post infarct.


Eligibility criteria:
inclusion criteria: * between 2-12 weeks post ischemic or hemorrhagic stroke * assessed eligible to participate in cardiorespiratory exercise by the patient's primary physiotherapist and interdisciplinary team -≥18 years old exclusion criteria: * uncontrolled medical contraindications for physical activity * severe hearing deficit or cochlear implants * severe deficit of both auditory and visual communication not allowing for guiding the patient in the exercise task
oral nutritional supplements in treatment of elderly mild-to-moderate covid-19

Conditions: Nutrition, Healthy

Summary: the coronavirus disease 2019 (covid-19) pandemic has seriously threatened public health worldwide. nutritional supplements may have a positive influence on the recovery of patients with viral infection. this study aimed to assess the influence of oral nutritional supplements (onss) on the biochemical parameters of elderly patients with mild-to-moderate covid-19. this clinical trial will be conducted on 145 elderly patients with mild-to-moderate covid-19. patients in the intervention group (n=74) received nutritional powder (vitamins, minerals, dietary fiber, polyphenols, omega-3, amino acids, and probiotics) for 14 days. cases in the control group (n=71) took the placebo, except for nutritional powder, and they received the same treatment. biochemical parameters were measured before and two weeks after intervention.

the coronavirus disease 2019 (covid-19) pandemic has seriously threatened public health worldwide. nutritional supplements may have a positive influence on the recovery of patients with viral infection. this study aimed to assess the influence of oral nutritional supplements (onss) on the biochemical parameters of elderly patients with mild-to-moderate covid-19. this clinical trial will be conducted on 145 elderly patients with mild-to-moderate covid-19. patients in the intervention group (n=74) received nutritional powder (vitamins, minerals, dietary fiber, polyphenols, omega-3, amino acids, and probiotics) for 14 days. cases in the control group (n=71) took the placebo, except for nutritional powder, and they received the same treatment. biochemical parameters were measured before and two weeks after intervention. after 14 days, patients in the groups will be measured by c-reactive protein (crp), creatinine (cr), blood urea nitrogen (bun), and interleukin-8 (il-8) ,white blood cell (wbc), red blood cell (rbc), platelet (plt), neutrophil percentage (ne%), prothrombin time (pt), d-dimer (dd), blood glucose, sodium (na+), potassium (k+), aspartate aminotransferase (ast), glutamate pyruvic transaminase (alt), albumin, calcium (ca), arterial blood gas (abg) parameters, and interleukin-10 (il-10).

Eligibility criteria:
inclusion criteria: 1. covid-19-positive was confirmed by reverse transcription-polymerase chain reaction (rt-pcr); 2. mild-to-moderate covid-19 patients who aged 60-90 years old; 3. consistency with the indication of enteral nutrition; 4. the time from diagnosis of covid-19 to hospitalization was less than 24 h. exclusion criteria: 1. oxygen saturation \< 93% or mechanical ventilation was required; 2. systemic diseases (malignant tumors, autoimmune diseases, liver or kidney diseases); 3. participation in other clinical trials within 3 months; 4. history of allergy to nutrients in the trial.

Keywords: oral nutritional supplements
impact of neurally adjusted ventilator assist (nava) mode on patient ventilator asynchrony using helmet

Conditions: Non-Invasive Positive-Pressure Ventilation

Summary: non invasive ventilation has been proposed to reduce the incidence of ventilatory dysfunction following abdominal aortic surgery. however, the nasogastric tube reduces the airtightness of the facial mask used to perform non invasive ventilation and induces air leaks. the use of a helmet reduces air leaks, thus seems adequate to ensure patient-ventilator interface. however, the high dead space related to helmet volume is responsible for asynchrony between patient demand and ventilatory support delivery. the investigators hypothesized driving the ventilator based on a neural signal (diaphragm electrical activity) would reduce patient-ventilator asynchronies.


Eligibility criteria:
inclusion criteria: * patients with increased risk of postoperative ventilatory dysfunction following abdominal aortic surgery exclusion criteria: * contra-indication to non-invasive ventilation pregnancy.
adjuvant epirubicin/cytoxan followed by a taxane vs. epirubicin/taxane as treatment for node-positive breast cancer

Conditions: Adenocarcinoma

Summary: the purpose of this study is to compare two combinations of drugs, epirubicin given with a taxane (et) or epirubicin given with cyclophosphamide (cytoxan) and followed by a taxane to see if one of the combinations is better at preventing or delaying the time for breast cancer recurrence and death after 3 years. the study will also evaluate the side effects of both treatment combinations.


Eligibility criteria:
inclusion criteria: * breast cancer stage t1-3, n1, m0 * suitable candidate for anthracycline-containing adjuvant chemotherapy exclusion criteria: * evidence of residual tumor following surgery, or metastatic disease * received prior therapy for breast cancer
a study to describe the real world use of bosutinib in the uk and netherlands

Conditions: Chronic Myeloid Leukaemia

Summary: the purpose of this study is to describe the efficacy and safety of bosutinib in patients with chronic myeloid leukaemia used in a real world setting


Eligibility criteria:
inclusion criteria: * diagnosis of ph+ cml aged ≥18 years at bosutinib initiation. * prescribed bosutinib (irrespective of the phase of their disease) either in normal clinical practice since it received marketing authorisation (27th march 2013) by the ema11 or via the compassionate use programme prior to marketing authorization. * where required, evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. exclusion criteria: * prescribed bosutinib as part of an interventional clinical trial programme. * initiated on bosutinib less than 3 months prior to data collection taking place.

Keywords: bosutinib chronic myeloid leukaemia retrospective observational
topiramate for treatment of patients with borderline personality disorder and alcohol dependence

Conditions: Alcohol Dependence; Borderline Personality Disorder

Summary: the objective of the present study is to evaluate the efficacy of topiramate (250mg/day) versus placebo in decreasing aggression and reducing alcohol consumption in patients with borderline personality disorder (bpd) and alcohol dependence (ad).

background: borderline personality disorder (bpd) affects about 2% of the american adult population. it is a very serious psychiatric disorder that places heavy demands on mental health resources. behavior dysregulation (impulsivity, self-injurious acts, drinking or aggressive behavior) is considered one of the main features of bpd and is associated with significant clinical morbidity. alcohol abuse is common among patients with bpd, and the co-morbid rates of alcoholism in bpd patients are estimated to be 30%. it has been hypothesized that alcohol misuse may be a manifestation of bpd's behavioral dysregulation. also, bpd and alcohol dependence (ad) share a common underlying neurobiology. the co-occurrence of these disorders has been associated with increased rates of alcohol relapse, impulsive behaviors, greater resistance to treatment, and suicidal behavior. effective treatment for patients with bpd and ad would result in markedly reduced health care costs and a substantial reduction in human distress and suffering. despite dramatic advances in the treatment of bpd, to date, no single medication or types of medications have been uniquely identified as effective in treating bpd. studies treating patients with co-morbid bpd and ad are expressly lacking. research design and methodology: this is an 8-week double-blind outpatient clinical trial of oral topiramate (250mg) vs placebo in individuals with bpd and ad. the study will be conducted at the west haven, ct va. thirty men and women with a current diagnosis of bpd and ad will be enrolled. the state-trait anger expression inventory (staei) will be used to assess 5 aspects of aggression: state anger, trait anger, anger expressed inwardly, anger expressed outwardly, and anger control before and during treatment (weeks 0-8). the timeline follow-back (tlfb) method will be used to document the degree of daily alcohol consumption before and during treatment (90 days before treatment, and weeks 0 - 8). emergent side effects will be assessed using the modified version of the systematic assessment for treatment emergent events (saftee).

Eligibility criteria:
inclusion criteria: * diagnosis of ad * diagnosis of bpd exclusion criteria: * serious or unstable medical condition * opiate dependence * major axis i disorder (bipolar disorder, schizophrenia) * taking mood stabilizers and antipsychotic medications * lft abnormalities that do not exceed 3 times normal values

Keywords: treatment topiramate alcohol dependence borderline personality disorder
late permissive hypercapnia for intubated and ventilated preterm infants

Conditions: Premature Neonate

Summary: preterm infants, less than 37 weeks gestation with respiratory distress syndrome, who remain ventilated between 7 and 14 days after birth will be randomized to a ventilator strategy of either a higher level of permissive hypercapnia or of a lower level of permissive hypercapnia to determine if either strategy will increase the number of alive ventilator-free days in the 28 days after randomization.

22.0 to 36.6 weeks gestational age preterm infants with respiratory distress syndrome, who remain ventilated between 7 and 14 days after birth will be randomized to one of two ventilator strategies: 1) a higher level of permissive hypercapnia or 2) a lower level of permissive hypercapnia to determine if either strategy will increase the number of alive ventilator-free days in the 28 days after randomization. after parental consent obtained, intubated, mechanically ventilated infants will be randomized by use of sequentially numbered sealed opaque envelopes to the treatment assignment. randomized infants will be stratified by gestational age at delivery (\< 26 weeks, ≥ 26 wks but less than 29 weeks, and ≥ 29 weeks). multiple births will be randomized to the same group. the envelope will be opened only on days 7-14 when infant meets criteria. clinicians will follow pre-specified algorithms of extubation and reintubation criteria to wean infants from mechanical ventilation. the ventilation algorithms may be set aside until the infant is deemed stable enough to allow resumption of the study algorithm. infant will be extubated within 24 hours of meeting extubation criteria and documented on a single blood gas. a trial of extubation per attending physician is allowed independent of the trial protocol.all other care is per unit standard. reports of routine follow-up after discharge in babies \< 27 weeks gestation will be obtained to determine neurodevelopmental impairment on this subset of babies.

Eligibility criteria:
inclusion criteria: * gestational age at least 22 but less than 37 weeks; * intubated on mechanical ventilation for respiratory distress syndrome on days 7-14 after birth; * admitted to neonatal intensive care unit before 7 days after birth; * informed consent per parent(s) exclusion criteria: * major malformation * neuromuscular condition that affects respiration * terminal illness * attending physician has made a decision to withhold or limit support for the infant

Keywords: respiratory distress syndrome permissive hypercapnia ventilator strategy
experiential training for community therapists

Conditions: Anxiety

Summary: the primary goal of this study is to evaluate the feasibility and acceptability of employing an experiential training approach that targets community mental health therapists' attitudes toward and use of exposure therapy. in addition to assessing attitudes and use of exposure therapy, the study will evaluate the feasibility of recruitment, randomization, retention, and assessment processes, as well as the acceptability of the experiential training relative to training-as-usual. to assess these outcomes, community therapists will be randomized to experiential training or training-as-usual. a subset of therapists from each arm will also complete qualitative interviews to further assess acceptability of the training approaches. the training-as-usual condition will include a traditional one-day workshop that focuses on principles of exposure and incorporates active learning strategies. the experiential training will include a one-day workshop that teaches principles of exposure and has therapists themselves undergo a one-session phobia treatment for spiders. therapists in both training conditions will be asked to attend weekly consultation phone calls for a three-month period following the trainings.


Eligibility criteria:
inclusion criteria: * participants will be aged 21 and older with degrees (masters or doctorate) in a mental health field. they must be working in a community mental health clinic, currently treating at least one client with anxiety, and planning to continue providing therapy to at least one client with anxiety for the duration of the study. participants must be interested in participating in a training workshop and able to commit to the time requirements for study completion. they must also be willing to provide an email or mailing address to complete study-related surveys. finally, they must be able to read and speak english. exclusion criteria: * participants cannot have previously attended a full day (8+ hours) workshop on exposure-based treatments for anxiety.
subconjunctival injection of allogeneic mesenchymal stem cells in severe ocular chemical burn

Conditions: Bone Marrow Donor

Summary: the objective of this pre-clinical study is to demonstrate the robustness of bone marrow derived mesenchymal stem cells (bm-msc) production, to treat patients with severe eye burns. for bone marrow donors who agree to participate, a 10 ml bm sample will be collected apart the 1 liter bm dedicated to transplantation. a maximum of three donors of allogeneic bm-mscs will be included. a ready-to-use bm-msc suspension will be produced and stored for 10 years to accumulate data about stability of cryopreserved cells.


Eligibility criteria:
inclusion criteria: - patient with a bone marrow donation planned exclusion criteria: * the donor is finally not eligible * the harvest cannot be performed * the sample cannot be obtained during the bm harvest procedure

Keywords: bone marrow harvest bone marrow derived mesenchymal stem cells (bm-msc) pre-clinical
a phase 3, open-label extension of courage-als (cy 5031)

Conditions: Amyotrophic Lateral Sclerosis

Summary: the purpose of this study is to assess the long-term safety and tolerability of reldesemtiv in patients with als who have successfully completed dosing in the phase 3 clinical trial, cy 5031 (also known as courage-als)

cy 5032 is an open-label extension (ole) study of the selective fast skeletal muscle troponin activator, reldesemtiv, in patients with als who finished dosing (through week 48) in cy 5031 (courage-als). approximately 400 patients from the sites that participated in cy 5031 are expected to be enrolled in the open-label extension, cy 5032. following enrollment, patients will continue dosing with reldesemtiv, 300 mg twice a day for a 600 mg total daily dose (tdd) for a period of 48 weeks. at the end of 48 weeks, patients may transition to a reldesemtiv managed access program (map) if the treating physician agrees to participate in the program.

Eligibility criteria:
inclusion criteria: * able to comprehend and willing to sign an icf and willing to comply with all study procedures and restrictions for the duration specified in the schedule of activities. if non-written consent is given, a legal designee of the patient must sign the icf form. * completed dosing in cy 5031 exclusion criteria: * has taken investigational study drug (other than reldesemtiv) prior to dosing, within 30 days or five half-lives of the prior agent, whichever is greater * presence on day 1 of any medically significant cardiac, pulmonary, gastrointestinal, musculoskeletal, or psychiatric illness that might interfere with the patient's ability to comply with study procedures or that might confound the interpretation of clinical safety or efficacy data. * use of a strong cytochrome p450 (cyp) 3a4 inhibitor within 7 days prior to first dose of reldesemtiv in cy 5032 or a strong cyp3a4 inducer within 14 days prior to first dose of reldesemtiv in cy 5032 * use of a medication that is an oct1/oct2 substrate within 7 days prior to first dose of reldesemtiv in cy 5032 * currently participating in another trial, managed access program, open label extension, early access program, or through the right to try act is receiving an investigational drug or received an investigational drug or device within 30 days (or 5 half-lives for drugs, whichever is longer) prior to day 1. patients also cannot be taking outside of a clinical trial certain investigational drugs (which includes drugs, supplements, and nutraceuticals) that are currently being studied or have been studied for the treatment of als.

Keywords: amyotrophic lateral sclerosis als ck-2127107 reldesemtiv
a study to evaluate safety, tolerability and p-glucose after multiple ascending oral doses of azd1656 in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to assess safety and tolerability of azd1656 after multiple repeated oral doses in patients with type 2 diabetes


Eligibility criteria:
inclusion criteria: * male or surgically sterile female of non-childbearing potential (post-menopausal, ie natural or induced menopause with last menstruation \>1 year ago and lh and fsh in the post-menopausal range, and/or have undergone hysterectomy and/or bilateral oophorectomy * diagnosed diabetes mellitus patients treated with diet and exercise alone or with up to two oral anti-diabetic drugs. stable glycemic control indicated by no changed treatment within 3 months prior to enrollment * hba1c ≤10.5 % at screening (hba1c value according to international dcct standard) exclusion criteria: * clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the ip * history ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease * clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results. positive test of hepatitis b surface antigen, antibodies to hiv virus and antibodies to hepatitis c virus

Keywords: type 2 diabetes
a study to see if we can predict how your liver tumor or liver metastases will respond to trans-arterial embolization (tae)

Conditions: Liver Cancer; Liver Metastases

Summary: the purpose of this study is to see if certain genes the tumor can help predict how the tumor will respond to trans-arterial embolization (tae). a gene is the basic physical and functional unit of heredity. genes are made up of dna; dna (deoxyribonucleic acid) is the hereditary material in humans. identifying a gene that can predict how liver tumors will respond to tae will also help to determine if adjuvant therapy will be needed after tae.


Eligibility criteria:
inclusion criteria: * histopathologic evidence of primary liver cancer or liver metastases * indication of tae for the treatment of liver tumor * age ≥ 18 years * available tissue with adequate tissue for analysis, verified by a pathologist exclusion criteria: * history of a second active malignancy with evidence of metastatic disease

Keywords: molecular predictors hepatic trans-arterial embolization (tae) 16-385